Restrictions Workshop Report

EUROPEAN COMMISSION INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs DIRECTORATE-GENERAL Consumer, Environmental and Health Technologies ENVIRONMENT DIRECTORATE-GENERAL Green Economy

Annex I

Workshop on implementation of the recommendations of the restriction task force and discussion on new restriction proposals

19-20 January 2016

Introduction

The aim of this workshop was to discuss the implementation of the recommendations of the Restriction Efficiency Task Force (RETF), especially the recommendations related to ECHA’s Committees, and to enable a discussion between Committee members and Dossier Submitters on any remaining difficulties to see if any further recommendations are required. Special sessions were dedicated to those issues which had not been fully discussed by the RETF in the past, such as the analysis of alternatives and some socio-economic aspects (particularly related to SEAC discussions). In addition, the workshop aimed to stimulate Member States to prepare and submit new restriction proposals, where appropriate. Overall the participants considered that implementing the recommendations of the RETF has improved the restriction process. Discussions were harmonious and very constructive including for differences in points of view between Dossier Submitter and Committees. The agenda can be found in Appendix 1.

Day 1 (Tuesday 19 January 2016)

Welcome and Introduction Klaus Berend, Head of the REACH Unit of DG GROW, opened the workshop wishing the participants a fruitful discussion. He expressed appreciation of the work done by the RETF and the implementation of the recommendations, and he encouraged Member States, ECHA Committees, FORUM, ECHA Secretariat and the Commission, to work together for the better efficiency of the restriction process. He also recalled that proper implementation of a restriction is vital to ensure that the restriction has an actual impact in terms of protection of human health or the environment. The activities of the FORUM in this regard show that restrictions are enforced, which is a strong encouragement to introduce new restrictions as there is proof that it is worthwhile to do so. Session 1: Using consultants efficiently Presentations on how to use consultants more efficiently and effectively were given by Matti Mannonen and Jaap de Koning (European Federation of Engineering Consultancy Associations - EFCA). The presentations covered the specification of the expected work, how to select a consultant and how to get the most out of consultants. They pointed out that the new procurement Directive encourages those planning a call for tender to hold an information session before calling for tenders and to interview tenderers. The information sessions can be

European Commission B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. Office: BREY 12/224 Telephone: direct line (32-2) 295.27.37. Fax: (32-2) 298.88.21. E-mail: [email protected] Office: BU-9 05/037 Telephone: direct line (32-2) 299.581.94 Fax: (32-2) 299.22.49. E-mail: [email protected] European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland Office: 3122 Telephone: direct line +358 9 6861 8122 E-mail: [email protected]

carried out over webex.

During the discussion it was mentioned that it is sometimes difficult to get usable information from consultants and they are not so good at developing a full restriction dossier. However, they can be useful to collect information, for example from industry and literature. The new legislation on procurement gives some new options but it may not be easy for public authorities to use them, e.g. pay bonuses when expectations are exceeded or apply performance based remuneration. It was also discussed how to use past performance as a criterion in selection.

The workshop participants concluded that it would be useful to share names of consulting companies or consultants that have helped in preparation of restriction proposals and to share best practices amongst Dossier Submitters.

Session 2: Restriction Efficiency Task Force (RETF) State of play The Commission (Giuseppina Luvarà, DG GROW) gave feedback on how the recommendations adopted by the RETF have been implemented for recent dossiers, and for opinions evaluating those dossiers, and what experience has been gained so far. Similar feedback had already been provided during the last CARACAL session in November 2015.

The Commission appreciated the new format of the Annex XV restriction report and how the information is condensed and justified in the report with Annexes. The Commission also appreciated the focus on detailed technical discussions by the two Committees and the attempt to avoid political discussions. It has become clear that there is a need to improve the effectiveness of the public consultation, in particular to obtain the maximum information that the two Committees need to make thorough assessments. Socio-economic factors should be better addressed already in the first consultation phase rather than only during the last 60 days when the draft SEAC opinion is already in a well-advanced stage. The two cases of DecaBDE and PFOA made it clear that there is a need for further investigations related to recycling, possibly with a view to developing a general approach. The Commission appreciated that the publication of comments submitted in the public consultation, including the answers to the specific questions posed, is published monthly. Still, it considered that some critical responses may need to receive a faster reply to stimulate further comments during the public consultation. All uncertainties should be fully documented in the Background Document in order to give the Commission all the elements needed for its final evaluation and decision.

Mark Blainey (ECHA) explained how the RETF recommendations, particularly those that relate to the Committees, had been implemented. The effort to reduce information requests to the Dossier Submitters during the opinion making and better prioritise those requests that are made was highlighted as one key improvement made. In addition, ECHA has revised the templates for the conformity check and opinion development, and has produced a framework, from conformity check to opinion building, to guide the Committees and improve consistency in their opinions. The ECHA Secretariat continues to improve the process further, for example through feedback from the Dossier Submitters (periodical contacts with Member States, and also after each plenary of the two Committees). Session 3: Improving Public Consultation Marko Sušnik (Economic Chamber of Austria - WKÖ and European Association of SMEs - UEAPME) informed about how WKÖ collects information for submission in public consultations, what constraints they have experienced to date and how they feel their comments have been considered during the opinion making process (both, for restrictions but also in other procedures such as harmonised CLP). They would like to see an upfront assessment of impacts on SMEs to be included in the documentation before launching of the public consultation. The public consultation for restriction is the best managed compared to other consultations, however the language used is still a problem as most documents are only provided in English. Some improvements should also be made to enable SMEs to understand the essential information more easily. SMEs are not always familiar with substance identifiers such as CAS or EC numbers. Other identifiers, for example the substance type and its use, or

the group of articles containing the substance, could be usefully described on the consultation webpage.

Sufficient participation of SMEs in the public consultation is still a difficulty, in particular to ensure that they are actually reached and can quickly evaluate the impact a proposal would have on them. Their voice on impacts and innovative technologies should be given greater attention already during the preparation of the Annex XV dossier.

Mark Blainey (ECHA) presented how ECHA has improved the public consultation on Annex XV dossiers and SEAC opinions. The key questions are drafted only in English. The 'e-news alert' from ECHA is sent to approximately 17 000 entities who have signed-up with ECHA to receive news alerts. These are mostly companies but also some associations, NGOs and academic institutions are in the contact list.

ECHA works with the Rapporteurs to write the ‘response to comments document’ (RCOM) which is published on their website. The RETF recommended that missing information should not stop the Committees making decisions and if no information on costs is submitted, the Committees can assume that cost concerns are low, considering that the public consultation allows a wide audience to contribute. Some comments were made on how difficult it was to upload reactions and to download the RCOM document due to its enormous size, with a lot of embedded and often repetitive attachments. A practical solution, to be proposed by ECHA, would be very welcome.

Some Member States stated that ECHA and the Commission were best placed to reach SMEs. However, the Commission recalled that despite the existing contact list and networks available to ECHA and the Commission, Member States authorities are best placed to consult (certainly so at national level), as they have access possibilities that are not available to ECHA or the Commission, for example chambers of commerce with mandatory membership. ECHA informs Member States of the start of each public consultation and asks for them to further publicise it in their countries. The multilingualism of the comments received was a concern in terms of time and resources invested by the Secretariat and the Committees. However, the Commission recalled that all official languages of the Member States may be used and mentioned that the Commission's Translation Department had developed a new automatic translation tool that could help in this regard.

The quality and reliability of comments received from Stakeholders and how to verify their input still remain problematic during the opinion making process. The Commission invited the Rapporteurs and ECHA to seek, where considered necessary, direct contacts with those having provided comments and investigate further as was done during the DecaBDE and PFOA restriction process. Otherwise this will have to be done by the Commission following receipt of the opinions, which is less effective.

Session 4: Identifying relevant restriction proposals Giuseppina Luvarà (DG GROW) gave a presentation on the Commission’s thinking on how best to approach the preparation of an Annex XV dossier for restriction on chemicals contained in tattoo inks. Following a request of the Commission to ECHA sent in December 2015, it is expected that a restriction dossier will be submitted to the two Committees in 2017. The approach proposed takes into consideration the list of chemicals in the Resolution of the Council of Europe (2008) as well as the list of chemicals prohibited, restricted and permitted in the different Annexes to the Cosmetic Products Regulation. Substances banned for use in cosmetics (those listed in Annex II to the Regulation) should be automatically banned from use in tattoo inks under a restriction in REACH. In such cases, there is the need to have a more qualitative assessment rather than a full quantification in terms of risks or socio- economic analysis (SEA). The same approach could be followed for other chemicals, which present concerns for mucous membranes or which are skin sensitisers or eye irritants. It was emphasised that REACH will only cover the chemicals in the inks as other aspects

related to tattooing, such as sterilisation of needles, hygiene in premises and the training of tattooists cannot be harmonised through REACH.

The Commission's presentation was complemented by a presentation of Susanne Bahrke from the Council of Europe: She illustrated the details of the substance list in the Council of Europe resolution. The Council of Europe is continuing its work, setting up positive lists of chemicals that may be used in tattooing.

Some Member States’ representatives were interested in working with ECHA in the preparation of the Annex XV dossier, but they needed to check internally before fully committing themselves. There was general agreement on a grouping approach for those substances which present a similar hazard profile.

Christian Heidorn (DG ENV) presented recent experiences with restriction proposals, recalled what triggered the various actors (Member States, ECHA and the Commission) to make proposals and presented some ideas on how to select chemicals for further restrictions, such as national concerns, international activities, substance evaluation under REACH, and other sectorial Union legislation.

Some participants welcomed the idea of better cooperation between Member States during the RiME discussions on restriction as the most appropriate risk management option; others wanted to look more into interfaces with other legislation such as the Industrial Emissions Directive, the Water Framework Directive and Occupational Safety & Health legislation.

Session 5: Enforceability of restriction proposals Karin Rumar and Eugen Anwander presented the activities of the Forum including the latest guidance for Dossier Submitters which will be adopted soon. The Forum advice on enforceability emphasises the relevance of the availability of analytical methods and the need for clear wording in the proposal for restriction. Although so far advice is provided only once by the Forum in the restriction process, the Forum stressed that it welcomes specific questions during the opinion making process in order to enhance enforceability.

Day 2 (Wednesday 20 January 2016)

Session 6: Lessons learned by Dossier Submitters and Committees from earlier dossiers Case of PFOA

Annegret Biegel-Engler (DE) and Ingunn Correll Myhre (NO) presented the Dossier Submitter’s view of the case, Steve Dungey the RAC point of view and Johanna Kiiski the SEAC perspective.

Dossier preparation remains a resource-intensive process (2.5 person years and up to €635 000 of consultancy fees in this specific case). The proposal had a very wide scope in terms of chemicals and uses but it was felt on the Committees’ side that the process had worked well. The evaluation was complicated, considering the wide scope and the socio-economic analysis related to PBT substances. The Commission considered that in such cases the two Committees should consider spending more time on discussion. In this specific case, ECHA considered most discussions were conducted within the available plenary sessions and therefore the need for an extension of the deadline was not an issue. It was debated whether to assess the human health properties of a PBT or just focus on the environmental effect of the substances and while the assessment of human health risks does not always appear necessary, this can be relevant for the socio-economic analysis. It was discussed how the DS took into consideration information provided by stakeholders in preparing the proposal and that this should be documented in the proposal to avoid repetitive submissions or late arrival of some information in the process. It was also discussed how much the Committees should amend the proposal of the DS (e.g. by including additional derogations or considering an alternative

RMO) but several participants and the Commission emphasised that this was part of the process. In addition, the Commission recalled that the RETF had already reflected on how the Committees can deviate from the RMO proposed and analysed in the Annex XV dossier. Managing information provided during the public consultation was considered a very heavy task due to the format of comments submitted and duplicative responses received. ECHA will invest some resources to help the dossier submitters and the rapporteurs to better screen information submitted.

Case of DecaBDE

Mark Blainey (ECHA) presented the Dossier Submitter’s perspective, Steve Dungey the RAC perspective and Endre Schuchtár the SEAC perspective.

Some discussion on PBT and wide scope took place in relation to decaBDE as for PFOA. Some information submitted during the public consultation was incomplete, such as the quantification of emissions to justify further derogations and details relating to spare parts and recycling. It was proposed to adopt a general approach to the issues of recycling, spare parts and stocks, which would help stakeholders to better target their comments in the public consultation and give some guidance to the Committees during the opinion making process. The particular approach taken would of course always depend on the specific case.

Session 7: Analysis of alternatives Mark Blainey (ECHA) presented a project launched by ECHA on the 'Analysis of Alternatives' focusing on how Member States and industry can find better alternatives. Several participants said that ECHA’s alternatives project was interesting and either had information to give or would like to be involved.

During the discussion, it was clarified that industry might not always go for the cheapest alternative once a substance they use is restricted and it is important to understand whether this will be the case early in dossier preparation and it should be reflected it in the analysis. For PFOA, many alternatives were identified and these were assessed in groups. It was agreed that looking for substitutes is difficult; in the D4/D5 case some information on substitutes was considered confidential by the industry stakeholders consulted by the Dossier Submitter. There may not be a substitute that meets all the technical requirements of the substance to be restricted. Analysis of alternatives should not only focus on substances but also on the availability of other technologies providing the same function.

Other issues discussed included the extent of information needed (hazard vs. risk) and how to make a comparison if the substitute has very different hazard properties from those of the restricted substance. As regards the properties of the alternative substances to be reported, there may not always be information on risks. Although Annex XV to REACH explicitly refers to available information on risks, most information presented to date on alternatives is on hazards. There were some suggestions to use a risk profile approach instead of a full risk assessment but this may only be possible for environmental risks. If there is a need for more than one substance to duplicate the technical function of the restricted substance (i.e. a mixture) this further complicates the use of risk profiling. It was also discussed that conducting a full risk assessment for alternatives (especially a comparative risk assessment) would be very difficult and may hinder the submission of dossiers. It was agreed that this issue would need to be further discussed.

Session 8: Socio-economic aspects Manol Bengyuzov (DG GROW) presented the views of the Commission on certain socio- economic aspects with the aim to fuel a discussion that may contribute to further improvement of the SEA process for restrictions. He explained why SEA is needed how it is carried out, and emphasised its importance for the decision-making. He noted that derogations need sound but proportionate justification, they need to identify problematic issues as early as possible, and to consider who is affected and how and what are the distributional impacts. He also presented the available resources for dossier submitters and

clarified how proportionality is approached in terms of socio-economic assessment. Kalle Kivela gave an update on a 'meta-analysis of restrictions' being carried out by ECHA.

During the discussion, it was stressed that SEA is needed and should be performed by the Dossier Submitter. It was discussed if qualitative analysis only would suffice for the opinion- making process, and whether costs should always be quantified (or at least sound assumptions made that can be tested in the Public Consultation). He also mentioned that benefits are normally more difficult to quantify and should hence be presented at least qualitatively and quantified where possible. Dossier submitters and subsequently SEAC assess proportionality on this basis. The effort in identifying and quantifying costs and benefits should be duly documented. It was raised that issues such as recycling, stocks and second hand goods are common to many restriction dossiers and it would be useful to develop a common approach to deal with them. It was also mentioned that other SEA elements, such as distributional effects, impacts on SMEs and employment are relevant for the decision-making and should be analysed both in the Annex XV dossier and the opinions/justifications if information is available. Finally whilst it was presented that there are potentially several possible understandings of proportionality, it was clarified that in the context of SEAC’s evaluations, proportionality currently refers to the comparison of the costs and the benefits of the proposed measure. It was clarified this is already made evident in the SEAC opinion template

Conclusions It was concluded that the workshop was very useful and had taken place in a constructive spirit of cooperation. The format of the workshop, bringing together Commission, Member States, ECHA, the Committees and the FORUM was found very useful and should be used again for discussions on other important issues.

Workshop participants confirmed that there have been improvements in support for the Dossier Submitter and in handling proposals generally. The Committee members expressed appreciation to the ECHA Secretariat for its support. Some more recommendations for improvement were identified. These will be listed in the report of the workshop and introduced at a future CARACAL meeting. The presentations will be circulated by ECHA. Appendix 1: Agenda

EUROPEAN COMMISSION INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs DIRECTORATE-GENERAL Consumer, Environmental and Health Technologies ENVIRONMENT DIRECTORATE-GENERAL Green Economy

Brussels, 19-20 January 2016

Draft Agenda Workshop on implementation of the recommendations of the restriction task force and discussion on new restriction proposals 19-20 January 2016 Centre A. Borschette, Rue Froissart, 36 – Brussels

TUESDAY, 19 JANUARY 2016 TIME (APPROX.)

REGISTRATION 08:30-09:00

MORNING SESSION

OPENING AND PRESENTATION OF THE WORKSHOP

Welcome and Introduction 09:00-09:10 Klaus Berend (REACH Head of Unit - DG GROW)

SESSION 1: USING CONSULTANTS EFFICIENTLY CHAIR: MATTI VAINIO, ECHA

Presentation on how to use consultants more efficiently and effectively 09:10-09:40 (Matti Mannonen and Jan van der Putten, EFCA (European Federation of Engineering Consultancy Associations) Discussion 9:40-11:00

COFFEE BREAK 11:00-11:20

SESSION 2: RESTRICTION TASK FORCE (RETF) STATE OF PLAY CHAIR: MATTI VAINIO, ECHA

Commission feedback on implementation of the Task force recommendations 11:20-11:40 (Giuseppina Luvarà, DG GROW) Update on progress of implementation of recommendations, particularly on those 11:40-12:00 related to the Committees (Mark Blainey, ECHA) 12:00-12:45 European Commission B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. Office: BREY 12/224 Telephone: direct line (32-2) 295.27.37. Fax: (32-2) 298.88.21. E-mail: [email protected] Office: BU-9 05/037 Telephone: direct line (32-2) 299.581.94 Fax: (32-2) 299.22.49. E-mail: [email protected] European Chemicals Agency Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland Office: 3122 Telephone: direct line +358 9 6861 8122 E-mail: [email protected]

Discussion

LUNCH 12:45-13:45

AFTERNOON SESSION

CHAIR: CHRISTIAN HEIDORN, DG ENV

SESSION 3: IMPROVING PUBLIC CONSULTATION

Presentation from stakeholder(s) on effectiveness of PC for restriction proposals 13:45-14:10 Marko Susnik (WKÖ and UEAPME) Progress with improving the PC for restriction proposals (Mark Blainey, ECHA) 14:10-14:35 Discussion 14:35-15:35

Session 4: Identifying relevant restriction proposals

Commission presentation on Tattoos (Giuseppina Luvarà,DG GROW) 15:35-16:00 Presentation by Susanne Bahrke Consumer Health Protection-European Directorate for the Quality of Medicines & 16:00-16:20 HealthCare (EDQM), Council of Europe Identifying relevant restriction proposals: How COM, MS and ECHA can co- 15:40-16:15 operate to find and prepare restriction proposals (Christian Heidorn,DG ENV)

COFFEE BREAK 16:15-16:40

Discussion 16.40-17.30

Session 5: Enforceability of restriction proposals

Usefulness of Forum guidance and Forum input into the restriction process 17:30-17:50 (Karin Rumar and Eugen Anwander) Discussion 17:15-18:15 End of the first day

WEDNESDAY, 20 JANUARY 2016 TIME (APPROX.)

REGISTRATION 08:30-09:00

MORNING SESSION

CHAIR: GIUSEPPINA LUVARÀ, DG GROW

SESSION 1: LESSONS LEARNT BY DS AND COMMITTEES FROM EARLIER DOSSIERS

Case of PFOA 09:00-10:00 Presentation of DS: Annegret Biegel-Engler and Ingunn Correll Myhre (DE/NO) Presentation of a RAC Member: Steve Dungey (co-rapporteur RAC) Presentation of a SEAC Member: Johanna Kiiski (rapporteur SEAC)

CASE OF DECABDE 10:00-11:00 Presentation of DS: Mark Blainey (ECHA) Presentation of a RAC Member: Steve Dungey (rapporteur RAC)

Presentation of a SEAC Member: Endre Schuchtár (co-rapporteur SEAC)

DISCUSSION 11:00-12:30

LUNCH 12:45-13:45

AFTERNOON SESSION

CHAIR: MARK BLAINEY, ECHA

SESSION 2: ANALYSIS OF ALTERNATIVES

Presentation of a project looking at development of analysis of alternatives in the 13:45-14:00 context of regulatory chemical risk management (e.g. restriction): Mark Blainey Discussion 14:00-14:45

Session 3: Socio-economic aspects

Presentation of Commission : Manol Bengyuzov (DG GROW) 14:45-15:00 Discussion 15:00-15:40

Wrap up and conclusions 15:40-16:00

End of the second day 16:00